Home NDC 70199-008-30 Robinul Forte
Product NDC 70199-008
Requested package NDC 70199-008-30
11-digit product format 701990008
Labeler code 70199
Product ID 70199-008_1c57b7db-a3c3-4635-b324-a3ebfa585feb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glycopyrrolate
Dosage form TABLET
Route ORAL
Labeler Casper Pharma LLC
Application NDA012827
Marketing category NDA
Marketing start 2020-10-06
Marketing end 0000-00-00
Substance GLYCOPYRROLATE
Active strength 2 mg/1
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N012827-001 ROBINUL GLYCOPYRROLATE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AA RLD, Approved before 1982 N012827-002 ROBINUL FORTE GLYCOPYRROLATE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AA RLD, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N012827-001 ROBINUL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AA RLD, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N012827-002 ROBINUL FORTE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AA RLD, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N012827-001 AA 1 a50c72e98297…2026-08-01 22:54:32 2026-06 N012827-002 AA 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70199-008-30 70199000830 30 TABLET in 1 CONTAINER (70199-008-30) 30 tablet 2020-10-06 0000-00-00 No No Current